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Background The purpose of this study was to assess the efficacy and safety of trabectedin for advanced breast cancer. Patients and Methods In an open-label, phase II, multicenter study, women with advanced breast cancer previously treated with ≤ 2 lines of chemotherapy for advanced disease, including both anthracyclines and taxanes, were randomized (1:1) to 3-hour infusions of trabectedin 1.3 mg/m2 once every 3 weeks (1/3 treatment arm) or 0.58 mg/m2 every week for 3 of 4 weeks (3/4 treatment arm). The primary end point was objective response. Secondary end points included time to progression (TTP), progression-free survival (PFS), and overall survival (OS). Results Fifty-two women (median age, 50 years; median chemotherapy agents, 4) were enrolled. Relative trabectedin dose intensities were 81% and 76% in the 1/3 and 3/4 treatment arms, respectively. Objective response rates were 12% (3 of 25) and 4% (1 of 27), respectively. Stable disease was observed in 14 (56%) and 11 (41%) patients in the 1/3 and 3/4 treatment arms, respectively, with median durations of 3.5 and 3.7 months. Median TTP and PFS were higher in the 1/3 treatment arm (3.1 months each) than in the 3/4 treatment arm (2.0 months each). At a median follow-up of 7 months in both treatment arms, median OS was not reached in the 1/3 treatment arm and was 9.4 months in the 3/4 treatment arm. The most frequent drug-related adverse events in the 1/3 and 3/4 treatment arms, respectively, were alanine aminotransferase (ALT) level increases (68% vs. 63%), nausea (56% vs. 59%), and asthenia (56% vs. 48%). Neutropenia and increases in ALT levels were the most frequent grade 3/4 events. Both types of events were usually transient and reversible. Conclusion In the population studied, trabectedin showed a manageable safety profile for both regimens analyzed. There were higher objective response rates and a longer PFS in the 1/3 treatment arm compared with the 3/4 treatment arm.

Background The concept of metronomic chronic administration of low-dose chemotherapy has become relevant for the treatment of cancer in the last several years. This study sought to determine the safety and activity of oral vinorelbine (VNB), using a metronomic schedule of administration, in elderly patients with metastatic breast cancer (MBC). Patients and Methods From October 2004 to March 2007, 34 patients with MBC (median age, 74 years; range, 70–84 years) were treated with oral VNB at 70 mg/m 2 , fractionated on days 1, 3, and 5, for 3 weeks on and 1 week off, every 4 weeks, for a maximum of 12 cycles. The objective response rate was the primary endpoint. Results All 34 patients received at least 3 cycles of therapy and were evaluable. Two achieved complete responses (6%), and 11 achieved partial responses (32%). Median progression-free survival and median overall survival entailed 7.7 months (95% confidence interval, 6.9-9.05 months) and 15.9 months (95% CI, 13.1-15.91 months), respectively, for all patients. Conclusion The fractionated administration of oral VNB is well tolerated and presents promising activity in elderly patients with metastatic cancer, warranting further investigation in combination with other chemotherapy agents.